(111 days)
Not Found
No
The summary describes a standard infrared gas analysis device and does not mention any AI or ML capabilities.
No
The device is a monitor and analyzer of carbon dioxide concentration and respiratory rate; it does not provide any therapy or treatment.
Yes
The device measures, displays, and monitors carbon dioxide concentration and respiratory rate, which are physiological parameters used to assess a patient's respiratory status. While it doesn't diagnose specific diseases, monitoring these parameters helps clinicians assess a patient's condition and detect deviations that may indicate a problem, thus serving a diagnostic function.
No
The device description explicitly states it is a "miniature mainstream infrared gas analysis bench with an integrated user interface" and a "transducer," indicating it is a hardware device that performs physical measurements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EMMA Emergency Capnometer measures carbon dioxide concentration and respiratory rate directly from the breathing circuit. This is a measurement of exhaled gas, not a test performed on a biological sample taken from the body.
- Intended Use: The intended use describes monitoring respiratory parameters during anesthesia, recovery, and respiratory care. This is a physiological monitoring function, not a diagnostic test on a biological sample.
Therefore, the EMMA Emergency Capnometer falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.
The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.
Product codes
CCK
Device Description
The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
Summary of Performance Studies
The EMMA Emergency Capnometer demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
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510(k) Owner Name and Address: 1. PHASEIN AB Svärdvägen 15 182 33 Danderyd Sweden Telephone: 46-8-544-98-150 Fax: 46-8-544-98-169
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Contact Person: 2. David Weissburg Weissburg Associates Madison, Wisconsin Telephone: 1-608-770-0223
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- Date: 28 December 2006
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6 2007 FEB
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Trade Name: EMMA Emergency Capnometer 4.
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Common Name: Carbon Dioxide Gas Analyzer ട.
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- Classification Names:
- a. Carbon dioxide gas analyzer (21 CFR 868.1400, Product Code CCK)
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- Substantially equivalent to:
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Device description: The EMMA Emergency Capnometer is a miniature mainstream 8. infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.
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ക Intended Use:
The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.
The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.
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- Comparison to predicates: The EMMA Emergency Capnometer combines carbon dioxide measurement capabilities and enhanced portability. The EMMA Emergency Capnometer uses the same basic technology concepts of the predicate devices, while adding improvements derived from advanced electronics and miniaturization. The intended use of the EMMA Emergency Capnometer and its predicates are equivalent. All the devices utilize disposable single-patient-use airway adapters to interface with gases in the breathing circuit. Labeling and materials used are equivalent.
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- Testing vs. predicates: Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
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- Conclusions from testing: The EMMA Emergency Capnometer demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Phasein AB C/O Mr. David Weissburg Weissburg Associates 4213 Winnequah Drive Madison. Wisconsin 53716
FEB 6 2007
Re: K063167
Trade/Device Name: EMMA Emergency Capnometer Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: January 3, 2007 Received: January 10, 2007
Dear Mr. Weissburg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Weissburg
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: _
EMMA Emergency Capnometer Device Name:
Indications for Use:
The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.
The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult and pediatric patients.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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